Mer­ck, Pfiz­er line up a big FDA de­ci­sion on a block­buster hope­ful, star­ing down some ma­jor league com­pe­ti­tion

Two Big Phar­ma col­lab­o­ra­tors — Mer­ck and Pfiz­er — have moved their SGLT2 di­a­betes drug hope­ful er­tugliflozin in­to the hands of reg­u­la­tors on both sides of the At­lantic.

Sam En­gel, Mer­ck

Armed with pos­i­tive piv­otal da­ta, Mer­ck and Pfiz­er are up for three PDU­FA dates in De­cem­ber now: Monother­a­py, a com­bo with best­selling di­a­betes drug Janu­via and an­oth­er com­bi­na­tion with long­time di­a­betes stan­dard met­formin. The same trio of ap­pli­ca­tions is al­so now un­der re­view in Eu­rope.

Said Sam En­gel, MD, as­so­ciate vice pres­i­dent, Mer­ck clin­i­cal re­search, di­a­betes and en­docrinol­o­gy: “If ap­proved, we be­lieve er­tugliflozin will be an im­por­tant op­tion for many pa­tients and a wel­come ad­di­tion to our al­ready strong type 2 di­a­betes port­fo­lio, with our DPP-4 in­hibitor Janu­via as the foun­da­tion.”

The mag­ic num­ber for A1C is 7.0%, which tells pa­tients that the dis­ease is be­ing well man­aged and un­der con­trol. And in the two drug arms for the phar­ma gi­ants’ piv­otal da­ta, 32.1% and 39.9% of pa­tients cleared that bar—com­pared to a less than stel­lar 17% of the place­bo arm. In­ves­ti­ga­tors al­so tracked a rel­e­vant 4.4 and 3.7 pound place­bo-ad­just­ed weight loss for their drugs. And there were sig­nif­i­cant­ly im­proved lev­els of fast­ing plas­ma glu­cose.

If they win an ap­proval, the Mer­ck/Pfiz­er team will face ma­jor league SGLT2 com­pe­ti­tion. Eli Lil­ly’s Jar­diance has been in the spot­light with a huge car­dio out­comes study in its fa­vor. And J&J’s In­vokana hit the mar­ket close to four years ago as the pi­o­neer­ing new drug in the class.

Not will­ing to play sec­ond fid­dle to Jar­diance, Mer­ck and Pfiz­er are well in­to their own big car­dio out­comes study, VER­TIS CV, with 8,000 re­cruits in the study. But they won’t get the fi­nal read­out un­til 2019.

Lil­ly, in the mean­time, won an ex­pand­ed la­bel and boast­ing rights for Jar­diance on the car­dio­vas­cu­lar out­comes at the end of 2016, even though it just bare­ly won the ex­pert pan­el vote af­ter reg­is­ter­ing a 38% drop in the risk of death. The prospect of an ex­pand­ed mar­ket boost­ed some es­ti­mates of the drug’s po­ten­tial peak sales to as high as $5 bil­lion or even $6 bil­lion a year. Lil­ly may nev­er get that far, but the num­bers haven’t es­caped the at­ten­tion of Mer­ck and Pfiz­er, which clear­ly be­lieve they can com­pete for a share.

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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The Avance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

As­traZeneca trum­pets the good da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Bris­tol My­ers Squibb fi­nal­ly gets in the front­line NSCLC game dom­i­nat­ed by Mer­ck, adding a sec­ond Op­di­vo/Yer­voy-based op­tion

Bristol Myers Squibb may be trailing Merck and Roche in the checkpoint race to treat frontline cases of non-small cell lung cancer, but as it does, it makes sure to bring its best feet forward.

Just days after scoring a landmark NSCLC approval for Opdivo and Yervoy alone for PD-L1 positive patients, the company said the FDA has also OK’d using the two agents with a limited course of chemo regardless of the biomarker status.

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No­var­tis jumps in­to Covid-19 vac­cine hunt, as Big Phar­ma and big biotech com­mit to bil­lions of dos­es

After spending most of the pandemic on the sidelines, Novartis is offering its aid in the race to develop a Covid-19 vaccine.

AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

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Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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